I'm no fan of statins because when I took Lipitor it gave me liver disease and elevated test readings that lasted for months even after I stopped taking it. Now that does not make me biased for or against the drugs. It does make me stop and look closely at the statistics and claims to see if I am seriously at risk for not taking this class of drugs. The editorial writer of NEJM and the science writer at the Times have also raised critical questions about the relative and absolute value of the benefits of this drug for this population and by extension of the general use of the whole class of pharmaceuticals.

Another series of red flags for me are the pom-pom waving physicians who make quotable assessments and the multi-million dollar ad campaigns that subtley terrify folks about risks of heart attacks and death.

That personal episode and my critical nature vis a vis the surrounding hullabaloo that is absolutely not acceptable in any professional scientific research community together gave me plenty to think about. Here are some of my thoughts that echo many of the NEJM and Times' themes and cautions...

There are at least two sides to every study. Your government now permits companies making cholesterol drugs to overstate the results of their studies and to reap enormous financial benefits from "preventative medicine" that is of statistically little value.

Let's look at how some spokesmen tout the latest results for a study of Crestor in a sample population.

One doctor, Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio, referred to the findings as an "out- of-the park home run" that will change medical practice. Now, that kind of assessment is just plain unprofessional. Dr. Nissen acts like a cheerleader, not like a professional and he ought to be disciplined for that.

And the news reports say that, "In the Crestor study, dubbed Jupiter, patients on the drug were 47 percent less likely to have a heart attack, stroke or die of cardiac causes after two years than those using a placebo."

So wait, that means that 47 percent of people who took the drug were cured of a disease, doesn't it?

But the real results for each individual who takes the drug are spelled out by Dr. Mark Hlatky of Stanford University in an editorial accompanying the report, published online by the New England Journal of Medicine:

Overall, the study found 83 heart attacks, strokes and deaths from cardiac causes among the 8,901 patients given Crestor, or 0.9 percent, compared with 157 in the 8,901 patients, 1.8 percent, getting a placebo. That means 120 people would need to be treated for 1.9 years to prevent just one event, Hlatky wrote in his editorial.

This drug does not cure heart disease or stroke. It lowers risk by a very small percent.

The number needed to treat is enormous. Out of 240 people in a year, you might prevent one event in one person. For you, and for each person that is less than a half a percent of cure, not 47 percent.

Or another way to look at it is the drug is less than one percent better than placebo.

The Times explains i this way:

Only 1.8 percent of the subjects who took a placebo had a major cardiovascular problem during the study period. Among statin users, 0.9 percent did. In other words, the absolute risk of a serious cardiovascular problem (as opposed to the relative risk) was reduced by less than one percentage point.

“Absolute differences in risk are more clinically important than relative reductions in risk in deciding whether to recommend drug therapy,” The New England Journal of Medicine noted in an editorial accompanying a report on the study.

And by the way, did we mention that those who took it develop a statistically significant risk of diabetes?

This drug does not provide any cure for any disease. The study gives truncated evidence that the drug is a relative risk reducer of small merit, with possible debilitating side effects for a given population.

For you and for me it is a bunt, if not a foul ball, surely not an out of the park home run.

And nobody bothers to explain convincingly why a study designed for five years was suddenly ended after two years. Was the initial design wrong? Who stopped the study? Why not keep it going? What are they afraid of? Hmm, perhaps even the misleading numbers won't hold up in a longer study.

Smells to me like the company saw a glimmer of daylight and cut and ran for it.

5 comments:

Shmendrik
said...

And the news reports say that, "In the Crestor study, dubbed Jupiter, patients on the drug were 47 percent less likely to have a heart attack, stroke or die of cardiac causes after two years than those using a placebo."

So wait, that means that 47 percent of people who took the drug were cured of a disease, doesn't it?

----

No, and you'd have to be a moron who thought that the incidence of heart attacks in the general population is about 100% to read it that way.

Obviously, you're biased because you experienced a rare side effect from taking a statin - I wish I had known that when we argued about this before.

I have been taking zocor for almost twenty years. I am now the oldest living male in my family's history for several generations. And I am, boruch hashem, free of the heart disease that plagued my father from age fifty till his death at 58. My 28 year old son is on a statin that has brought his cholesterol into the normal range. Perhaps you should have tried another statin. My brother-in-law had to switch from zocor to lipitor. Save the problems that a small percentage of people have with statins, it seems that their wide spread use is related to the huge drop in deaths from early heart attacks that were so prevalent a generation back.

I’m glad that people are questioning the advisability of statins for all! Even if it’s true (and I believe it is) that patients with high levels of C-Reactive Protein are at higher risk for heart attacks (even with normal cholesterol levels), WHY do doctors think statins should be the FIRST treatment considered?

Following the publicity surrounding the JUPITER/Crestor study, some experts pointed to studies showing that nutritional supplements also lower CRP levels. Dr. Andrew Saul referenced several of these studies in his article, “Why treat nutritional deficiency with drugs?” ( http://orthomolecular.org/resources/omns/v04n22.shtml ).

These studies have been published in medical journals: the American Heart Association’s “Circulation,” “Diabetes Care” and “The European Journal of Clinical Nutrition,” etc., and are catalogued by PubMed. I list (and link to) 7 of these studies in an article on my website, “Statins (Crestor) for Everyone? Or Could Diet and Nutritional Supplements Do the Job Better?”. It’s at http://tinyurl.com/6k752j .

Paul Ridker, MD, who conducted the JUPITER/Crestor study, was quoted on WebMD’s professional news service, Heartwire, as saying that “. . . diet alone can have a substantive effect on lowering CRP levels.”

So the study found that among those taking the drug, 0.9 percent suffered a heart attack, compared with 1.8 percent of those getting a placebo.

I don't understand why you take issue with the conclusion that the risk of heart attack was reduced by 47%. For you to say that this is really a minor reduction of less than 1% on an absolute basis is just silly. Using that reasoning, if nobody using Crestor suffered a heart attack, you could blow off its importance by saying that the reduction was less than 2%!